Drugmakers Want To Sell Cialis Over The Counter

The maker of the popular erectile dysfunction drug Cialis would like the pill to be sold over the counter.

Sanofi and Eli Lilly would be the first to offer such drugs without a prescription. Cialis, which is also used to treat an enlarged prostate, was approved by the U.S. Food and Drug Administration in 2003 by prescription only.

The two companies hope to have an over the counter version of the drug available in 2018, which they are calling Cialis OTC. That is the same year patents expire for Cialis in the United States and Europe, allowing cheaper generics to take over and effectively dry up Lilly’s profits, reported USA Today.

Cialis generated sales of $2.2 billion in worldwide in 2013, and it was Lilly’s fourth best-selling drug. More than 45 million people worldwide have used it.

If approved for over the counter use, Cialis could gain an advantage over competitor Viagra, sold by Pfizer. However, it is not clear whether the FDA would approve it. In 2008, Pfizer abandoned a move to make Viagra available without a prescription after the European Medicines Agency raised concerns, as reported by The New York Times.

“Millions of men worldwide trust Cialis to treat E.D.,” said David A. Ricks, president of Lilly Bio-Medicines, the part of Lilly that oversees Cialis. “We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from E.D. to obtain convenient access to a safe and reliable product without a prescription.”

Cialis can be dangerous when take with certain heart medications that contain nitrates, which may be a concern for regulators.

Many men, not willing to visit a doctor for a prescription or seeking lower prices, have turned to buying the drug online, where many of the websites are actually selling it illegally. Last year, Pfizer began selling Viagra through its own website.

The move to make Cialis easier to obtain by removing a visit to the doctor has its own concerns.

Dr. Kevin L. Billups, a urologist at the Johns Hopkins School of Medicine, said erectile dysfunction can be an early sign for more serious health problems, such as heart disease and diabetes.

“Maybe you’re missing an opportunity to pick up something else,” said Dr. Billups, the director of the school’s Men’s Health and Vitality Program.

Sanofi’s experience in conducting consumer studies and gaining approval for over the counter versions of other drugs, including the allergy medications Nasacort and Allegra, was one reason Lilly chose to partner with the French drug maker.

[Image via npr.org]